Infant head-shaping pillows are useless and dangerous to baby, FDA warns

Infant head-shaping pillows are not approved by the U.S. Food and Drug Administration and should not be used, the agency warned Thursday.

The pillows can create an unsafe sleep environment for infants, potentially contributing to the risk of suffocation and death.

Marketed as changing an infant’s head shape or symmetry or claiming to treat other medical conditions, they have no demonstrated benefit, the agency said in a news release.

“If you own an infant head-shaping pillow, throw it away; do not donate or give it to anyone else,” the alert said. “Be aware that infant head shaping pillows are not safe or effective for preventing or treating flat head syndrome or other medical conditions.”

In most cases, flat head syndrome will go away on its own as an infant grows up, the FDA said. It is not painful and it does not cause any developmental concerns. Using a head-shaping pillow may delay necessary medical evaluations and mask something more serious, such as craniosynostosis, where a developing infant’s skull bones join together too early.

The U.S. National Institutes of Health and the American Academy of Pediatrics both recommend infants sleep on their backs in a bare crib on a flat—not inclined—surface without pillows, toys, soft objects or loose bedding.

These recommendations are intended to help reduce the risk of Sudden Unexpected Infant Death (SUID), a category that includes Sudden Infant Death Syndrome (SIDS).

Health care providers should discourage the use of infant head-shaping pillows and educate their patients about the risks, the FDA added.

Infant head-shaping pillows are typically small, with an indent or hole in the center designed to cradle the back of an infant’s head while the infant lays face up.

Some do not have the indent and are rectangular-shaped.

The FDA has cleared caps, helmets or head bands to improve head symmetry or shape in infants and toddlers from 3 months to 18 months of age.

Some devices are also intended for infants from 3 to 18 months of age whose head shape has been surgically corrected, but who still have a moderate-to-severe flat head, the FDA said.

The agency said it has communicated its concerns about promotional materials to companies that make these pillows and will continue to monitor claims for these products.

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Monkeypox in kids, teens is rare and seldom severe: CDC

Out of the more than 25,000 U.S. cases of monkeypox reviewed in a new study, just 0.3% occurred in people under the age of 18, new government data shows.

Most of the kids and teens who contracted the virus—89%—”were not hospitalized, none received intensive care unit [ICU]-level care, and none died,” reported a team led by Ian Hennessee, with the Monkeypox Pediatric Working Group at the U.S. Centers for Disease Control and Prevention.

Since its global emergence earlier this year, monkeypox, which is typically confined to Africa, has infected tens of thousands of people worldwide.

The viral illness is characterized by painful lesions and typically requires skin-to-skin contact to spread. The vast majority of cases have occurred among gay and bisexual men.

Cases among children and adolescents have remained rare. In their analysis, the CDC team looked at 25,038 U.S. cases occurring between mid-May and late September.

Of those cases, only a tiny fraction—83, or 0.3%—occurred in people under the age of 18. Fifty-five of those cases were among adolescents aged 13 to 17, and another 28 occurred in kids up to age 12.

How did the younger kids contract monkeypox? According to Hennessee’s team, 20 cases occurring in kids under the age of 13 had enough data available to hazard a guess.

In 19 of those cases, kids “were exposed in the household setting; for 17 of these children, the reported exposure was direct skin-to-skin contact that routinely occurs between a child and an adult caregiver,” the researchers reported.

In the 20th case, it’s suspected that the child contracted monkeypox after using an item, such as a towel, previously used by an infected adult.

Among the 35 cases among adolescents with available data (32 of whom were males), it’s thought that sexual contact was the primary mode of transmission, the CDC team said. Investigations showed no sign that sexual abuse was involved in any of these cases.

Fortunately, none of the children or teens infected with monkeypox in the United States required ICU care, the team reported.

None of the kids under the age of 13 had monkeypox lesions in the anogenital area, and if lesions were present they occurred mainly on the torso, the researchers noted.

Two children under the age of 5 did contract monkeypox rash that involved lesions on their eyelids, while another older child also had eye issues related to monkeypox—all three were hospitalized and later released.

Among the 55 adolescents with monkeypox, lesions occurred in the anogenital area in about 60% of cases, the CDC team reported. They said six of the cases were so serious as to require hospitalization, typically for “pain management, treatment of secondary bacterial infections, and systemic symptoms with rash.”

As happens with adult cases of monkeypox, many of the affected kids and teens received tecovirimat (TPOXX) and other medications as treatment.

While rare, cases of monkeypox in kids can occur, so “adults with monkeypox who interact with children in the household setting should follow transmission prevention guidelines to prevent the spread of monkeypox,” Hennessee’s group said. That includes covering up any lesions to minimize the risk of skin-to-skin contact.

Sexually active teens, especially boys involved in male-to-male sex, should consider getting the Jynneos vaccine, which can prevent monkeypox infection, the researchers added.

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Mothers’ recall of early childhood feeding guidance from health care providers is inconsistent

 

Health care providers (HCPs) usually conduct 14 wellness visits with children before the age of five, and are often a trusted source of information for mothers. A research article featured in the Journal of Nutrition Education and Behavior discusses mothers’ recollection of key feeding guidance recommendations that can affect children’s long-term health.

“Many studies have looked at the nutrition guidance shared by HCPs with the families of young children, but few studies have described what guidance parents recall receiving,” according to author Andrea McGowan, MPH, who was affiliated with the Division of Nutrition, Physical Activity, and Obesity, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, GA, at the time this study was conducted. “This study fills that gap by analyzing the specific topics mothers remember and what factors influenced that recall.”

Data for this analysis come from the 2017-2019 National Survey of Family Growth, conducted by the Centers for Disease Control and Prevention’s National Center for Health Statistics. Among the 6,141 women who participated in the study, 1,632 had a child aged six months to five years in their home at the time of the survey. These women were asked to recall their child’s HCP discussing when to introduce solid foods and guidance on the specific feeding topics referenced in “Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents” from the American Academy of Pediatrics.

The study asked questions related to offering foods with many different tastes and textures, not forcing a child to finish food or bottles, offering a variety of fruits and vegetables, limiting foods and drinks with added sugar, and limiting eating meals in front of the television or other electronics.

Lead investigator Andrea McGowan, MPH, discusses a new study that shows mothers’ recall of early childhood feeding guidance from health care providers is inconsistent. For example, less than 50% of mothers surveyed remembered advice from health care professionals to limit kids’ use of electronic devices during meals. Credit: Journal of Nutrition Education and Behavior

Among mothers who recalled their HCPs talking about the introduction of solid foods, 37% recalled being told to introduce solid food before six months, when the recommendation is to wait until about six months of age and not before four months. More than half of mothers recalled an HCP discussing between four and five topics on early feeding guidance, with 31% recalling only two or three topics.

Mothers with higher education levels or older mothers were more likely to recall these feeding discussions. Of the five nutrition topics, offering a variety of fruits and vegetables had the highest percentage of recall, while less than half of the mothers recalled the recommendation to limit meals in front of the television or other electronic devices.

“Pediatricians report spending an average of 18 minutes with children and their parents during wellness visits with many health topics covered during that limited time,” states McGowan. “Innovative strategies tailored to families’ needs might alleviate the HCP burden and could enhance parental recall, especially when messaging is culturally relevant and personalized.”

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History of eviction linked to child developmental risk

A history of evictions is associated with increased odds of child fair or poor health, developmental risk, and hospital admission from the emergency department, according to a study published online Sept. 19 in Pediatrics.

Diana B. Cutts, M.D., from Hennepin County Medical Center in Minneapolis, and colleagues used cross-sectional surveys from 26,441 caregiver or young child (younger than 48 months) dyads from 2011 to 2019 in emergency departments and primary care clinics. The relationships of a five-year history of formal and informal evictions with caregiver and child health were examined.

The researchers found that 3.9 percent of the 26,441 caregivers reported five-year eviction history; 57.0 percent were formal (court-involved) evictions. The associations were minimally different between formal versus informal evictions after controlling for covariates and, therefore, were combined. Evictions were associated with increased odds of child fair or poor health, developmental risk, and hospital admission from the emergency department compared with no evictions (odds ratios, 1.43, 1.55, and 1.24, respectively), and they were also associated with adverse caregiver and hardship outcomes. In sensitivity analyses adjusting separately for household income and housing-related hardships, the results were not significantly altered, but the odds ratios were attenuated and hospital admission from the emergency department was no longer significant.

“Although eviction’s causes and consequences may be complex and varied, findings suggest reduction of eviction incidence, formal and informal, may address health disparities and the needs of young families,” the authors write.

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New York pediatricians see an early surge in cases of RSV

Medical providers are seeing a surge in cases of respiratory syncytial virus, or RSV, across the country. In upstate New York, medical providers say they’re also seeing a rise in RSV.

RSV is usually the kind of virus that crops up during the late fall and winter season. But local pediatricians say this RSV season has started earlier than usual.

For bigger kids and adults without pre-existing conditions, RSV often simply feels like a cold. It doesn’t always require hospitalization. But providers say the problem is that because of pandemic safety measures, there has been a fairly light RSV season for the past two years.

Chris Kjolhede, an attending pediatrician at Bassett Healthcare Network in Cooperstown said because most people were wearing masks and staying at home, there was less RSV being spread around.

“So little kids didn’t get exposed. And then all of a sudden, we’re back to sort of normal: attending school, no masks…and the virus is out there. And it’s spreading like wildfire,” Kjolhede said.

Most kids are exposed to RSV by the time they turn five, Kjolhede said. That means the small children who weren’t exposed to RSV last year, and the year before that, all are developing symptoms now.

Philip Heavner, the system chief of Pediatrics at Guthrie,* a medical system with locations in the Southern Tier and Pennsylvania, said RSV numbers are three to four times what he usually sees this time of year.

“In a typical year, the kids who were born in the last year, who have never been through a winter where there was RSV, those are the ones who tend to be at risk—and kids with other health problems. We have three years of those now, we have three consecutive years where the kids didn’t get RSV. And so all three years are susceptible now,” Heavner said.

With COVID numbers on the rise again as the weather gets colder, and the flu season starting back up, doctors worry hospitals, ERs and outpatient services could end up swamped.

“When you get into a nasty respiratory season, and these kids do require things that need to be done in a hospital, it doesn’t take long for you to run out of space,” Heavner said.

Kjolhede said the one silver lining is the potential for a vaccine, which could protect especially high-risk patients, like newborns.

“For those of us who have weathered this with these kids and these families for so many years—you’re always biting your nails. ‘Do I need to put this kid on oxygen? Do I need to start an IV? Or can we just wait one more night?’—This is great news,” Kjolhede said.

Pfizer announced Tuesday that its RSV vaccine trial has had promising results. The vaccine is designed to be given to pregnant mothers, to protect newborns from RSV. The company will submit for U.S. Food and Drug administration approval by the end of the year.

In the meantime, both providers pointed out that many kids who don’t have other risk factors can be taken care of at home. Parents should watch for trouble breathing, a fever that doesn’t go down, and dehydration in small children and infants.

To protect small children and older family members from the spread of RSV, people should keep surfaces clean and wash their hands often.

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The maternal RSV vaccine from Pfizer protects newborns against severe illness

 

What is RSV?

RSV is the most common cause of respiratory infections in children aged two years and younger. In fact, some estimates indicate that over 60% of children will be infected with RSV by the time they reach one year of age, with nearly all children likely to be infected by age two.

RSV infection typically causes cold-like symptoms such as a runny nose, reduced appetite, coughing, sneezing, fever, and wheezing. Nevertheless, RSV can cause severe illness in a significant number of children under the age of one and, as a result, is the leading cause of death due to respiratory infections in this patient population.

Several factors can increase a child’s risk of severe illness due to RSV, which include age less than one year before or during peak incidence of the virus, as well as prematurity, low birth weight, and the presence of comorbidities such as congenital heart disease, chronic respiratory diseases, and immunodeficiency. In addition, children with an older sibling, as well as those who are exposed to cigarette smoke and are not breastfed, are also at a greater risk of severe RSV infection.

Every year we see high levels of RSV cases among babies in the U.S. with some regions reporting hospital admission rates higher than normal this year.”

Pfizer’s RSVpreF vaccine

There remains no specific treatment available for RSV infection; therefore, children infected with this virus, including those hospitalized with severe illness, typically receive symptomatic care until the infection eventually clears their systems. The lack of both preventative and antiviral treatments available for RSV has led Pfizer to develop and test the efficacy of a bivalent RSV perfusion vaccine candidate known as RSVpreF or PF-06928316.

Previous research conducted at the United States National Institutes of Health (NIH) has provided detailed information on the crystal structure of prefusion F, an important form of the RSV viral fusion (F) protein responsible for its entry into host cells. Moreover, antibodies specific to prefusion F were found to effectively prevent RSV infection from occurring.

This information was then used to support the development of RSVpreF, an investigational RSV vaccine candidate that comprises equal amounts of recombinant RSV prefusion F from subgroups A and B.

Clinical trial results

RSVpreF has been clinically evaluated in two trials, including the RSV vaccine Efficacy Study iNOlder adults Immunized against RSV disease (RENOIR) trial and the MATernal Immunization Study for Safety and Efficacy (MATISSE) study.

The MATISSE study is an ongoing randomized, double-blinded, placebo-controlled Phase III clinical trial study aimed towards evaluating the safety, efficacy, and immunogenicity of RSVpreF. To this end, about 7,400 pregnant women during the late second to the third trimester of their pregnancy were enrolled in the trial to receive a single dose of either Pfizer’s RSVpreF or the placebo vaccine.

Infants born to mothers who received either vaccine were followed for at least one year to determine the safety and efficacy of the vaccine. Furthermore, 50% of these infants were monitored for two years.

Vaccine efficacy of 81.8% for preventing severe lower respiratory tract illness (LRTI) was reported through the first 90 days of life. This high efficacy against severe illness was retained in 69.4% of infants by the time they reached six months of age.

In addition to the protection conferred against severe LRTI, Pfizer reports that the vaccine protected against non-severe medically attended LRTI in 57.1% and 51.3% of infants through the first 90 days and six months of life, respectively.

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Low school test scores linked to racial segregation and lead exposure in NC

 

Black children who have been exposed to the metal lead have lower test scores than their peers, and this effect is exacerbated for those who live in racially segregated neighborhoods, according to research led by a Duke environmental epidemiologist.

The findings appear the week of August 8 in the Proceedings of the National Academy of Sciences.

The researchers linked birth data, blood lead levels and fourth grade end-of-grade test scores for more than 25,000 children living in North Carolina to investigate how childhood lead exposure and neighborhood racial residential segregation affect early childhood educational outcomes.

“Our study concluded that it’s not just about where lead exposure is highest—that’s just one piece of the puzzle,” said Mercedes A. Bravo, Ph.D., assistant research professor at the Duke Global Health Institute and first author on the paper.

“Black children are more likely to be exposed to lead and are also more likely to live in racially segregated, predominantly Black neighborhoods,” Bravo said. “When these two exposures co-occur, children had worse than expected scores.”

Understanding how structural racism and environmental contamination, such as lead exposure, can combine to affect children’s health and development can help researchers, community stakeholders and public health departments identify and target the most vulnerable individuals and communities, Bravo explained.

Lead is a toxin that has been linked to cognitive and neurodevelopmental disorders in children. Although high levels of lead are unhealthy for children in general, structural racism may amplify the negative cognitive impacts of the lead exposure considerably, said Marie Lynn Miranda, Ph.D., senior author on the paper and director of the Children’s Environmental Health Initiative at the University of Notre Dame. Miranda is also an adjunct Professor of Pediatrics at Duke and was a longtime Duke faculty member.

“In the midst of our country’s racial reckoning, we must think more about and ultimately act on the deep effects that environmental justice and structural racism have on our country and our communities,” said Miranda. “This paper tackles both issues head on by showing that a clear issue of environmental justice (childhood lead exposure) is further compounded by the structural racism that Black families in particular face in the United States, as demonstrated through racial residential segregation.”

Identifying the mix of social, environmental and economic factors that create health disparities early could lead to earlier intervention in vulnerable communities, thus narrowing the “achievement gap” that becomes apparent in early childhood and persists or widens with time. This gap results in lower high school and college graduation rates among children who belong to racial and ethnic minority groups, the authors explain in the paper.

In North Carolina, children are most often exposed to high levels of lead through lead-based paint found in older homes. Other possible exposure sources are lead pipes, fittings, and solder in older houses and living near polluting sources or industries, such as airports, said Bravo. Racially segregated neighborhoods may be more likely to have one or more of these factors at play.

Although lead-based paint was banned in 1978, homes built prior to that time may still expose children in their own homes, explained Bravo, especially if the home has not been significantly renovated using lead-safe practices.

“Even if the home has been re-painted, chips and dust from the lead paint end up on the floor and window sills in the home or in the soil outside the home,” said Bravo. “Young kids often have a lot of hand-to-mouth behavior and spend time on the floor in their homes. Unfortunately, lead-based paint may taste good—it is said to taste sweet—which does not help in keeping kids away from the substance.”

Pipes that carry drinking water to the home may also contain lead, particularly if the pipes were made prior to 1986. When communities fail to replace these aging pipes at the appropriate time, health disasters can ensue like the Flint, Michigan crisis that was discovered in 2014.

Lastly, living near an airport can place children at higher risk for lead poisoning due to the leaded gas found in aviation fuel. Though the use of leaded gasoline in most motor vehicles was banned 25 years ago, leaded aviation fuel is still used because a safer alternative has not yet been developed, according to the U.S Federal Aviation Administration.

“This study reminds us that there is an enduring legacy of structural racism and environmental injustice that may be systematically disadvantaging specific groups and communities of children,” Bravo said. “Taking a more holistic approach to examining what children are exposed to in their physical and social environments is critical to addressing health disparities and advancing health equity.”

International Conference on Pediatrics, Perinatology and Child Health

12th Edition of PPCH | 12-14 December 2022 | Dubai, United Arab Emirates (Hybrid) Visit: http://pediatrics.pencis.com #PediatricsConferences #Perinatology #childHealth